Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of
development candidates, today announced topline results from the
Phase 2 proof-of-concept double-blind, randomized, multi-center,
placebo-controlled UPLIFT study of TNX-601 ER* (tianeptine
hemioxalate extended-release tablets) in patients with major
depressive disorder (MDD). The primary efficacy endpoint of change
from baseline in depression severity, as measured by the
Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did
not achieve clinical or statistical significance.
“Based on these efficacy results, we are
discontinuing development of TNX-601 ER. We look forward to topline
results from our Phase 2 study of TNX-1900 in chronic migraine in
early December and topline results from our Phase 3 potential
NDA-enabling study of TNX-102 SL in fibromyalgia in late December,”
said Seth Lederman, M.D., President and Chief Executive Officer of
Tonix Pharmaceuticals. “We would like to thank the patients, their
families, and all the investigators and researchers who
participated in the Phase 2 UPLIFT study.”
In the Phase 2 UPLIFT study, TNX-601 ER was
orally administered as monotherapy once a day to 132 patients who,
upon entering the study, met a DSM-5 diagnosis of
moderate-to-severe depression with a duration for the current major
depressive episode of at least 12 weeks. Efficacy was assessed
using the MADRS to measure any potential change in patients’
depression severity from baseline. In the study, TNX-601 ER was
generally well-tolerated with a favorable safety profile. There was
one serious adverse event (SAE) experienced in the placebo group,
and two SAEs in the active treatment group deemed possibly related
to study drug, both of which resolved without sequelae.
About the Phase 2 UPLIFT
Study
The Phase 2 proof-of-concept UPLIFT study,
TNX-TI-M201, is a double-blind, randomized, multicenter,
placebo-controlled study to evaluate the efficacy and safety of
TNX-601 ER taken orally once-daily for 6 weeks for the treatment of
moderate-to-severe MDD. It is a parallel design study with a
TNX-601 ER 39.4 mg arm and a placebo arm. A total of 132
participants were randomized in a 1:1 ratio into the two arms
across approximately 27 U.S. sites, enrolling adult patients 18-65
years old with a DSM-5 diagnosis of MDD and a duration for the
current major depressive episode of at least 12 weeks. The primary
efficacy endpoint is mean change from baseline in the MADRS total
score at Week 6. Key secondary efficacy endpoints include the
Clinical Global Impression - Severity Scale (CGI-S) and the Sheehan
Disability Scale (SDS).
For more information, see ClinicalTrials.gov
Identifier: NCT05686408.
About Major Depressive Disorder
(Depression)
According to the National Institute of Mental
Health, an estimated 21 million adults in the U.S. in 2020
experienced at least one major depressive episode1, with highest
prevalence among individuals aged 18-25 at a rate of 17.0%. For
approximately 2.5 million adults in the U.S., adjunctive therapies
are necessary for depression treatment.2,3 Depression is a
condition characterized by symptoms such as a depressed mood or
loss of interest or pleasure in daily activities most of the time
for two weeks or more, accompanied by appetite changes, sleep
disturbances, motor restlessness or retardation, loss of energy,
feelings of worthlessness or excessive guilt, poor concentration,
and suicidal thoughts and behaviors. These symptoms cause
clinically significant distress or impairment in social,
occupational, or other important areas of functioning. The majority
of people who suffer from depression do not respond adequately to
initial antidepressant therapy.4
1 Data Courtesy of SAMHSA on Past Year
Prevalence of Major Depressive Episode Among U.S. Adults 2020.
Retrieved from
http://www.nimh.nih.gov/health/statistics/major-depression.shtml
2 IMS NSP, NPA, NDTI MAT-24-month data through
Aug 2017.
3 Kubitz N, et al. PLoS One 2013, 8 (10),
e76882.
4 Rush AJ, et al. Am J. Psychiatry 2007, 163
(11), 1905-1917.
About TNX-601 ER
TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a novel oral formulation of tianeptine
designed for once-daily daytime dosing in development as a
candidate for the treatment of MDD. Tianeptine sodium (amorphous)
immediate release (dosed 3 times daily) was first marketed for
depression in France in 1989 and has been available for decades in
Europe, Russia, Asia, and Latin America for the treatment of
depression. Tianeptine sodium has an established safety profile
from decades of use in these jurisdictions. Currently no
tianeptine-containing product is approved in the U.S. and no
extended-release tianeptine product is approved in any
jurisdiction. Tonix discovered a novel oxalate salt of tianeptine
that may provide improved stability, consistency, and
manufacturability compared to known salt forms of tianeptine.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary, markets Zembrace®
SymTouch® (sumatriptan injection) 3 mg and Tosymra®
(sumatriptan nasal spray) 10 mg under a transition services
agreement with Upsher-Smith Laboratories, LLC from whom the
products were acquired on June 30, 2023. Zembrace SymTouch and
Tosymra are each indicated for the treatment of acute migraine with
or without aura in adults. Tonix’s development portfolio is
composed of central nervous system (CNS), rare disease, immunology
and infectious disease product candidates. Tonix’s CNS development
portfolio includes both small molecules and biologics to treat
pain, neurologic, psychiatric and addiction conditions. Tonix’s
lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl
sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia, having completed enrollment of a
potentially confirmatory Phase 3 study in the third quarter of
2023, with topline data expected in late December 2023. TNX-102 SL
is also being developed to treat fibromyalgia-type Long COVID, a
chronic post-acute COVID-19 condition, and topline results were
reported in the third quarter of 2023. TNX-1900 (intranasal
potentiated oxytocin), is in development as a preventive treatment
in chronic migraine, and enrollment has completed in a Phase 2
proof-of-concept study with topline data expected in early December
2023. TNX-1900 is also being studied in binge eating disorder,
pediatric obesity and social anxiety disorder by academic
collaborators under investigator-initiated INDs. TNX-1300 (cocaine
esterase) is a biologic designed to treat cocaine intoxication and
has been granted Breakthrough Therapy designation by the FDA. A
Phase 2 study of TNX-1300 is expected to be initiated in the fourth
quarter of 2023. Tonix’s rare disease development portfolio
includes TNX-2900 (intranasal potentiated oxytocin) for the
treatment of Prader-Willi syndrome. TNX-2900 has been granted
Orphan Drug designation by the FDA. Tonix’s immunology development
portfolio includes biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was
initiated in the third quarter of 2023. Tonix’s infectious disease
pipeline includes TNX-801, a vaccine in development to prevent
smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious
diseases, including TNX-1800, in development as a vaccine to
protect against COVID-19 . The infectious disease development
portfolio also includes TNX-3900 and TNX-4000, which are classes of
broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. All other marks are property of their respective owners.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on Tonix's
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, risks
related to the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; risks related to the
timing and progress of clinical development of our product
candidates; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and substantial
competition. As with any pharmaceutical under development, there
are significant risks in the development, regulatory approval and
commercialization of new products. Tonix does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in the Annual
Report on Form 10-K for the year ended December 31, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, and periodic reports filed with the SEC on or after the
date thereof. All of Tonix's forward-looking statements are
expressly qualified by all such risk factors and other cautionary
statements. The information set forth herein speaks only as of the
date thereof.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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